Drug injection device with visual and audio indicators

ABSTRACT

A drug injection device ( 10 ) including a housing ( 12 ) for holding a container ( 20 ) having a needle ( 24 ) for penetrating skin and a plunger ( 42 ) for expelling a drug stored in the container. The device includes visual and/or audible indicators for indicating that the correct depth of needle penetration has been achieved and that drug injection/extrusion has been started and/or completed. The device may further include a label ( 140 ) for visually confirming the quality of the drug contained therein. Alternatively, a tray ( 110 ) may be provided for receiving the drug injection device, which allows the quality of the drug contained therein to be visually confirmed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/501,953, filed Feb. 6, 2017, which is the United States nationalphase of International Patent Application No. PCT/US2015/055523, havingan international filing date of Oct. 14, 2015, which claims the prioritybenefit of U.S. Provisional Patent Application No. 62/063,737, filedOct. 14, 2014, which are all hereby incorporated by reference herein intheir entireties.

FIELD OF THE DISCLOSURE

The present disclosure relates to drug delivery devices. Moreparticularly, the present disclosure relates to a drug delivery orinjection device having visual and audible indicators associated withone or more of needle penetration, drug delivery, drug quality, andinjector orientation.

BACKGROUND

There are many diseases and conditions which may require a patient toinject themselves with a drug. Accordingly, drug injection devices suchas autoinjectors, injection pens, and the like, have been developed topermit a patient or user to conveniently and accurately self-administerproper doses of a drug.

In some injection devices, the injection needle may be fixed relative tothe primary container, therefore, the patient or user must apply a forceto pierce the skin to deliver the drug. Once the injection needle hasachieved the required depth of penetration, which is typicallycontrolled by the patient or user, a drive mechanism advances a plungerwhich delivers the drug contained in the primary container through theinjection needle.

Since the patient or user is responsible for the penetration depth, itwould be helpful to the patient or user if the drug injection device hadsome way of indicating to the patient or user when the correct depth hasbeen achieved. It would also be helpful if the drug injection devicecould indicate to the patient or user when other stages of the injectionprocess are occurring or have occurred and/or other information, whichfacilitate the convenient and accurate use of the device.

SUMMARY

Disclosed herein is a drug injection device. In various embodiment, thedrug injection device can include a housing, a container, a needleguard, and at least one indicia on the needle guard. The container canbe disposed within the housing and have a needle and a plunger. Thecontainer can be adapted to store a product for administration to apatient at an injection site. The plunger can be adapted to expel theproduct through the needle, wherein a portion of the needle extends outof the housing. The needle guard can be coupled to the housing adjacentto the needle of the container. The needle guard can be movable relativeto the housing between (a) a fully extended position wherein the needleguard extends from the housing and beyond the portion of the needleextending out of the housing, (b) an intermediate position wherein theneedle guard extends from the housing approximately the same distancethat the needle extends out of the housing, and (c) a fully retractedposition wherein a substantial portion of the needle extending out ofthe housing is exposed beyond the needle guard. The at least one indiciadisposed on the needle guard is for providing a visual indication of theposition of the needle relative to the injection site based on aposition of the needle guard relative to the housing.

In various embodiments, the at least one indicia can include at leastone of the following: (a) a color, (b) a text-based indicia, (c) animage, (d) a symbol, (e) a graphic, (f) a pattern, (g) an illuminatedvisual indicator.

In various embodiments, the device can further include at least onespring biasing the needle guard toward the fully extended position.

In various embodiments, the needle guard can include a unitary hollowcylindrical member.

In various embodiments, the needle guard can include an outer surfaceincluding a proximal outer surface portion and a distal outer surfaceportion such that (a) when the needle guard occupies the fully extendedposition, the proximal and distal outer surface portions are exposedoutside of the housing, (b) when the needle guard occupies theintermediate position, the proximal outer surface portion is concealedinside the housing and the distal outer surface portion is exposedoutside of the housing, and (c) when the needle guard occupies the fullyretracted position, the proximal and distal outer surface portions areconcealed inside the housing.

In various embodiments, the at least one indicia can include a firstindicia disposed on the proximal outer surface portion and a secondindicia disposed on the distal outer surface portion, the first indiciabeing visually distinct from the second indicia.

In various embodiments, the needle guard can include first and secondneedle guard members telescopically movable relative to each other.

In various embodiments, the first needle guard member can include afirst outer surface and the second needle guard member includes a secondouter surface such that (a) when the needle guard occupies the fullyextended position, the first and second outer surfaces are exposedoutside of the housing, (b) when the needle guard occupies theintermediate position, (i) the second outer surface is concealed insidethe first needle guard member and the first outer surface is exposedoutside of the housing, or (ii) the first outer surface is concealedinside the second needle guard member and the second outer surface isexposed outside of the housing, and (c) when the needle guard occupiesthe fully retracted position, the first and second outer surfaces areconcealed inside the housing.

In various embodiments, the at least one indicia can include a firstindicia disposed on the first outer surface of the first needle guardmember, and a second indicia disposed on the second outer surface of thesecond needle guard member, the first indicia being visually distinctfrom the second indicia.

In various embodiments, the device can further include a first biasingmember disposed between the housing and the first needle guard member,the first biasing member biasing the first needle guard member away fromthe housing, and a second biasing member disposed between the first andsecond needle guard members, the second biasing member biasing thesecond needle guard member away from the first needle guard member.

In various embodiments, the first biasing member generates a biasingforce greater than a biasing force generated by the second biasingmember.

In various embodiments, the needle guard can further include an outerrim disposed in engagement with the housing when the needle guardoccupies the fully retracted position, thereby limiting furtherretraction of the needle guard into the housing.

In various embodiments, the at least one indicia includes indiciadisposed on the outer rim.

In various embodiments, the device can further include an audibleindicator associated with the needle guard and configured to generate anaudible signal when (a) the needle guard moves to the intermediateposition from the fully extended position and/or (b) the needle guardmoves to the fully retracted position from the intermediate position.

In various embodiments, the housing can include at least one window ortransparent section that allows viewing of the container and/or plungerin the housing.

In various embodiments, the device can further include a temperatureindicator carried by the housing and adapted for indicating atemperature of a product in the container.

The disclosure also provides a tray for a drug injection device having ahousing for holding a container storing a drug therein, wherein thehousing including a window that allows viewing of the drug, the windowcomprising (a) one or more discrete windows in the housing of the druginjection device, or (b) a transparent 360 degree section of the housingof the container. The tray can include a support wall and a drug testsurface. The support wall defines a first recess adapted to hold thedrug injection device. The drug test surface can be disposed on thesupport wall, such that at least a portion of the drug test surface isdisposed in the recess immediately adjacent the window of the druginjection device when the drug injection device is disposed in the tray.So configured, the drug in the container can be compared against thedrug test surface to determine at least one of a clarity and a color ofthe drug by viewing the drug against the drug test surface through thewindow of the housing of the device.

In various embodiments, the drug test surface can be disposed under thesection of the housing of the device including the window if the deviceis disposed in the first recess.

In various embodiments, the drug test surface can include an area of afirst color for testing one of the clarity and the color of the drug.

In various embodiments, the drug test surface can include an area of asecond color for testing the other one of the clarity and the color ofthe drug.

In various embodiments, the drug test surface can include an instructionto determine the at least one of the clarity and the color of the drug.

In various embodiments, the tray may further include a second recessextending transverse to the first recess to allow for removal of thedrug injection device from the tray.

The disclosure also provides a drug injection device including a housingand a removable label. The housing is for holding a container storing adrug therein, the housing including a window that allows viewing of thedrug in the container, wherein the window comprises (a) one or morediscrete windows in the housing of the drug injection device, or (b) atransparent 360 degree section of the housing of the container. Theremovable label is disposed over the housing. The label can have firstand second sections, the second section of the label having an innersurface that defines a drug test surface disposed immediately adjacentto at least a portion of the window in the housing. So configured,removal of the first section of the label from the housing allows atleast one of a clarity and a color of the drug to be determined bycomparing the drug with the drug test surface of the second section ofthe label by viewing the drug through the window against the drug testsurface.

In various embodiments, the drug test surface includes an area of afirst color for testing one of the clarity and the color of the drug.

In various embodiments, the drug test surface includes an area of asecond color for testing the other one of the clarity and the color ofthe drug.

In various embodiments, the first section of the label has a firstinstruction to remove the first section to check the drug and a secondinstruction to determine the at least one of the clarity and the colorof the drug.

In various embodiments, the label further includes a third sectionhaving a first instruction to remove the third section of the label ifthe at least one of the clarity and the color of the drug is determinedto be proper and a second instruction to not use the device if the atleast one of the clarity and the color of the drug is determined to beimproper.

In various embodiments, the label includes a pull tab.

In various embodiments, the container includes a needle for penetratingskin and dispensing the drug stored in the container, at least a portionof the needle extending out of the housing and further includes a capfor enclosing the at least portion of the needle; wherein the label atleast partially covers the cap.

Yet various other embodiments of the drug injection device may comprisea housing for holding a container. The container may have a needle and aplunger, the needle for penetrating skin and the plunger for expelling adrug stored in the container through the needle, at least a portion ofthe needle extending out of the housing. A driver may be associated withthe housing for driving the plunger through the container. A needleguard may extend beyond the housing to enclose the at least portion ofthe needle extending out of the housing.

In various embodiments, an injection process may be commenced by placingthe needle guard of the device into contact with skin at an injectionsite and advancing the device towards the skin.

In various embodiments, the needle guard may move in the direction ofthe housing as the device is advanced towards the skin to visuallyindicate when the needle begins to penetrate the skin.

In various embodiments, as the needle guard moves in the direction ofthe housing, at least a portion of the needle guard may be at leastpartially concealed to provide the visual indication.

In various embodiments, the drug injection device may further comprisean audible indicator associated with the needle guard to audiblyindicate when the needle begins to penetrate the skin.

In various embodiments, the drug injection device may further comprisean audible indicator associated with the needle guard to audiblyindicate when the plunger begins to expel the drug from the container.

In various embodiments, the drug injection device may further comprisean audible indicator associated with the needle guard to audiblyindicate when the plunger has completed expelling the drug from thecontainer.

In various embodiments, the needle guard may be biased in an extendedposition.

In various embodiments, the needle guard may include color-based indiciafor visually indicating when the needle begins to penetrate the skin.

In various embodiments, the needle guard may include text-based indiciafor visually indicating when the needle begins to penetrate the skin.

In various embodiments, the needle guard may include color- andtext-based indicia for visually indicating when the needle begins topenetrate the skin.

In various embodiments, the housing may have an elongated bodycomprising first and second ends, wherein the first end of the body mayhave a first shape and the second end of the body may have a secondshape, which is different from the first shape to distinguish the firstand second ends of the body from one another.

In various embodiments, the shape of the body may gradually change fromthe first shape to the second shape.

In various embodiments, at least one of the first and second shapes mayinclude a flat or substantially surface to prevent the device fromrolling when placed on a support surface.

In various embodiments, one of the first and second ends of the body maycomprise a removable cap that encloses the needle guard.

In various embodiments, the housing may include at least one window thatallows viewing of the plunger, the plunger visually indicating when theinjection process has been completed.

In various embodiments, the at least one window may comprise a lens thatmagnifies the view of the plunger through the at least one window.

In various embodiments, the housing may include a transparent sectionthat allows 360 degrees of viewing of the plunger, the plunger visuallyindicating when the injection process has been completed.

In various embodiments, the transparent section of the housing mayinclude a lens that magnifies the view of the plunger through thetransparent section of the housing.

In various embodiments, the plunger may have a vivid color to facilitatethe viewing thereof

In various embodiments, the drug injection device may further comprise atemperature indicator.

In various embodiments, the drug injection device may further comprise alabel with non-slip features, the label attached to the housing.

In various embodiments, the needle guard includes first color-basedindicia for visually indicating when the needle begins to penetrate theskin and second color-based indicia for visually indicating when theplunger begins to expel the drug from the container.

In various embodiments, the needle guard may move in the direction ofthe housing as the device is advanced towards the skin to visuallyindicate when the needle begins to penetrate the skin and when theplunger begins to expel the drug from the container.

In various embodiments, as the needle guard moves in the direction ofthe housing, a first portion of the needle guard may be concealed toprovide one of the visual indications and a second portion or the entireneedle guard may be concealed to provide the other one of the visualindications.

In various embodiments, the needle guard may include first text-basedindicia for visually indicating when the needle begins to penetrate theskin and second text-based indicia for visually indicating when theplunger begins to expel the drug from the container.

In various embodiments, the needle guard may include first color- andfirst text-based indicia for visually indicating when the needle beginsto penetrate the skin and second color and second text-based indicia forvisually indicating when the plunger begins to expel the drug from thecontainer.

In various embodiments, the needle guard may include first and secondneedle guard members, wherein the first and second needle guard membersof the needle guard may sequentially move in the direction of thehousing as the device is advanced towards the skin to visually indicatewhen the needle begins to penetrate the skin.

In various embodiments, as one of the first and second needle guardmembers move in the direction of the housing it may be concealed toprovide the visual indication.

In various embodiments, the sequential movement of the first and secondneedle guard members of the needle guard may further visually indicatewhen the plunger begins to expel the drug from the container and whereinas one of the first and second needle guard members moves in thedirection of the housing it may be concealed to provide one of thevisual indications and as the other one of the first and second guardmembers moves in the direction of the housing may be at least partiallyconcealed to provide the other one of the visual indications.

In various embodiments, the first and second needle guard members mayeach be biased in an extended position.

In various embodiments, one of the first and second needle guard membersmay include first color-based indicia and wherein the other one of thefirst and second needle guard members may include second color-basedindicia.

In various embodiments, one of the first and second needle guard membersmay include first text-based indicia and wherein the other one of thefirst and second needle guard members may include second text-basedindicia.

In various embodiments, one of the first and second needle guard membersmay include first color- and first text-based indicia and the other oneof the first and second needle guard members may include secondtext-based indicia.

Further disclosed herein is a tray for a drug injection device having ahousing for holding a container storing a drug therein, wherein thehousing may include a window or a transparent housing section thatallows viewing of the drug. Various embodiments of the tray may comprisea drug test surface for comparing the drug with to determine at leastone of a clarity and a color of the drug by viewing the drug through thewindow or the transparent housing section.

In various embodiments, the tray may include a recess for holding thedrug injection device, wherein the drug test surface may be disposed inthe recess.

In various embodiments, the drug test surface may be disposed under thewindow or the transparent housing section if the device is disposed inthe recess.

In various embodiments, the drug test surface may include an area of afirst color for testing one of the clarity and the color of the drug.

In various embodiments, the drug test surface may include an area of asecond color for testing the other one of the clarity and the color ofthe drug.

In various embodiments, the drug test surface may include an instructionto determine the at least one of the clarity and the color of the drug.

Further disclosed herein is a drug injection device, which comprises aremovable label for confirming the quality of a drug contained in thedevice.

In various embodiments, the drug injection device may further comprise ahousing for holding a container, the container storing a drug therein.

In various embodiments, the housing may include a window or atransparent housing section that allows viewing of the drug in thecontainer.

In various embodiments, the removable label may be disposed over thehousing.

In various embodiments, the label may have first and second sections,the second section of the label having an inner surface that defines adrug test surface, wherein removal of the first section of the labelfrom the housing may allow at least one of a clarity and a color of thedrug to be determined by comparing the drug with the drug test surfaceof the second section of the label by viewing the drug through thewindow or the transparent housing section.

In various embodiments, the inner drug test surface may include an areaof a first color for testing one of the clarity and the color of thedrug.

In various embodiments, the inner drug test surface may include an areaof a second color for testing the other one of the clarity and the colorof the drug.

In various embodiments, the first section of the label may have a firstinstruction to remove the first section to check the drug and a secondinstruction to determine the at least one of the clarity and the colorof the drug.

In various embodiments, the label may further include a third sectionhaving a first instruction to remove the third section of the label ifthe at least one of the clarity and the color of the drug is determinedto be proper and a second instruction to not use the device if the atleast one of the clarity and the color of the drug is determined to beimproper.

In various embodiments, the label may include a pull tab.

In various embodiments, the drug injection device may further comprise acap which is at least partially covered by the label.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an elevational view of a drug injection device according toan embodiment of the disclosure, with certain elements of the deviceshown in cross-section.

FIG. 1B is a block diagram of an audible indicator mechanism for theinjection device according to an embodiment of the disclosure.

FIG. 2 is a perspective view of the drug injection device according toan embodiment of the disclosure.

FIG. 3A is a perspective view of the drug injection device according toanother embodiment of the disclosure.

FIG. 3B is a perspective view of the drug injection device according toanother embodiment of the disclosure.

FIG. 3C is a perspective view of the drug injection device according toanother embodiment of the disclosure.

FIG. 4A is a partial elevational view of a needle guard of the druginjection device according to an embodiment of the disclosure.

FIG. 4B is a partial elevational view of the needle guard of the druginjection device according to another embodiment of the disclosure.

FIGS. 5A-5D are elevational views of the drug injection device showingthe operation of the needle guard of FIG. 4A, according to an embodimentof the disclosure.

FIG. 6A is a partial elevational view of a needle guard of the druginjection device according to another embodiment of the disclosure.

FIGS. 6B-6D are elevational views of the drug injection device showingthe operation of the needle guard of FIG. 6A, according to an embodimentof the disclosure.

FIG. 7A is a partial elevational view of a needle guard of the druginjection device according to another embodiment of the disclosure.

FIGS. 7B-7D are elevational views of the drug injection device showingthe operation of the needle guard of FIG. 7A, according to an embodimentof the disclosure.

FIG. 8 is a plan view of a tray according to an embodiment of thedisclosure, for confirming the quality of the drug contained within thedrug injection device.

FIG. 9A is a perspective view of the drug injection device having alabel (shown in an open state) for confirming the quality of the drugcontained within the drug injection device, according to an embodimentof the disclosure.

FIG. 9B is a plan view of the drug injection device of FIG. 9A, whichshows the label wrapped around the device prior to its use to confirmthe quality of the drug.

FIG. 9C is a plan view of the drug injection device of FIG. 9B, whichshows the label in an open position, which allows it to be used toconfirm the quality of the drug contained within the drug injectiondevice.

DETAILED DESCRIPTION

FIG. 1A shows an embodiment of a drug injection device according to thepresent disclosure, denoted generally by reference numeral 10. Invarious embodiments, the drug injection device 10 may comprise anautoinjector for automatically delivering a subcutaneous injection of afixed or user/patient-settable dose of a drug. Autoinjectors are oftenassociated with a patient self-administering an injection, however, suchan injection may also be administered by a health care provider.Similarly, use of the drug injection device may be undertaken by eitherthe patient or health care provider.

As shown in FIG. 1A, the drug injection device 10 may be configured as apen-type device. Some embodiments of the drug injection device 10 may beconfigured as a disposable, single use device which delivers a fixeddose of the drug. In other embodiments, the drug injection device 10 maybe configured as a reusable device. Reusable drug injection devices 10may be constructed to deliver a multiple doses of a drug where the dosesof the drug may be fixed or user/patient-settable.

Referring still to FIG. 1A, the drug injection device 10 comprises ahousing 12 having a distal end 14 and a proximal end 16. The housing 12may have a generally elongated, tubular shape. The housing 12 may beopen at the distal end 14 and closed at the proximal end 16. The housing12 can be constructed as a single, unitary component or constructed frommultiple components or sections that are combined into a single,integral unit. The housing 12 in pen-type devices may be dimensioned tohold a single primary container 20. In other embodiments, the housing 12can be configured in other shapes and/or dimensioned to hold a pluralityof primary containers. The primary container 20 may be pre-filled with adrug 22. The primary container 20 may comprise a glass or plasticsyringe and may include an injection needle 24 through which the drug 22can be injected into a patient. The injection needle 24 may be removablyor non-removably secured to the primary container 20 and typicallyextends through the distal end 12 of the housing 12. A cap 30 may beremovably connected to the distal end 14 of the housing 22 for coveringthe injection needle 24. The housings 12 of reusable devices may beconfigured to allow removal and insertion of the primary container 20.

The device 10 may be configured so that the primary container 20 isfixed relative to the housing 12 as shown in FIG. 1A. In suchembodiments, the patient or user must apply a force to penetrate theskin with the injection needle 24 to deliver the drug 22. Various otherembodiments of the device 10 may include a drive mechanism for movingthe primary container 20 relative to the housing 12 to automaticallypenetrate the skin with the injection needle 24.

In still other embodiments, a portion or section of the housing may formthe primary container (not shown). The primary container in suchembodiments may be pre-filled with a drug. In such embodiments, theinjection needle may be removably or non-removably connected to thedistal end of the housing such that it communicates with the portion orsection of the housing forming the primary container.

Referring again to FIG. 1A, the primary container 20 may contain apiston 26, which seals an open end 28 of the primary container 20. Thepiston 26 can be slidably driven through the container 20 to expel thedrug 22 from the container 20 through the injection needle 24. A plunger42 may be provided for driving the piston 26 through the container 20.The plunger 42 may extend into the open end 28 of the primary container20 to directly or indirectly engage the piston 26. A drive mechanism 40may be provided for automatically actuating the plunger 42. The primarycontainer 20 may be transparent, partially transparent or translucent,to allow a patient or user to view the position of the plunger 42 withinthe container 20 as will be explained further on.

The drive mechanism 40 may comprise a mechanical arrangement of one ormore springs or an electrical/mechanical arrangement comprising one ormore motors and/or solenoids and a drive train or transmission. Thedrive mechanism 40 may include a microprocessor for controlling thedrive mechanism 40. In some embodiments, the microprocessor may allowdose setting. In other embodiments a mechanical dose setting arrangementmay be separately provided, which controls the distance that the drivemechanism 40 moves the piston 26 through the primary container 20 viathe plunger 42, to allow the patient or user to set the dose.

Referring still to FIG. 1A, a needle guard 50 may be provided at thedistal end 14 of the housing 20. The needle guard 50 is typicallyconfigured to surround the injection needle 24 to prevent accidentalneedle sticks when the device 10 is not being operated but when the cap30 is removed. In the present embodiment, the needle guard 50 caninclude a unitary hollow cylindrical member, as depicted in FIG. 1A, forexample. But other embodiments can take on different constructs, as willbe described below, for example in reference to FIGS. 6A-6D and 7A-7D.In some embodiments, the needle guard 50 may also activate the drivemechanism 40 when the device 10 is pressed down onto the injection site,which causes the needle guard 50 to move proximally relative to thehousing 12 from an extended position. Activation of the drive mechanism40 by the needle guard 40 may be realized using any suitable mechanicalarrangement, any suitable electrical arrangement, or any suitablecombination of a mechanical and electrical arrangement. Because sucharrangements are well known in the art, a further description of thesearrangements is not required herein.

In some embodiments, the needle guard 50 may comprise a cylindricalmember 52 having distal and proximal ends 54 and 56, respectively, asshown in FIG. 1A. The proximal end 56 of the needle guard 50 may becoupled to the housing 12. In the embodiment shown in FIG. 1A, theproximal end 56 of the needle guard 50 is arranged to be coupled withinthe housing 12 such that a substantial portion of the needle guard 50extends through the open distal end 14 of the housing 12 in a fullyextended position. A biasing element 57, such as a coil spring, may beprovided to bias the needle guard 50 in a fully extended position. Thebiasing element 57 may be disposed between the proximal end 56 of theneedle guard 50 and an abutment 12 a provided on an inner surface 12 iof the housing 12.

The device 10 may be operated by placing the needle guard 50 against theskin at the injection site, and then pressing the device toward theskin, which moves the needle guard 50 from the fully extended positionin which the injection needle 24 is fully surrounded by the needle guard50 to a substantially retracted position relative to the housing 12,which at least partially exposes the injection needle 24 and allows itto penetrate the skin at the injection site. In the embodiments wherethe needle guard 50 also activates the device 10, the movement of theneedled guard 50 from the fully extended position to the substantiallyretracted position activates the device 10. As the device 10 iswithdrawn from the injection site, after completion of the injection,the biasing element 57 returns the needle guard 50 back to the fullyextended position.

As shown in FIG. 2, the housing 12 may be configured so that the distalend 14 thereof and the cap 30 have a first shape 14 s (e.g.,cylindrical) and the proximal end 16 thereof has a second shape 16 s(e.g., triangular prism) which is different from the first shape 14 s todistinguish distal and proximal ends 14, 16 of the device 10 from oneanother. In some embodiments, the shape of the housing 12 may graduallychange from one of the first and second shapes 14 s, 16 s to the otherone of the first and second shapes 14 s, 16 s as one moves between thecap 30 and proximal end 16 of the housing 12. In some embodiments, atleast one of the first and second shapes 14 s, 16 s can include one ormore flat or substantially flat surfaces 15 to prevent the device 10from rolling when placed on a support surface.

Alternatively, as shown in FIGS. 3A and 3C, just the removable cap 30may be configured with one or more substantially flat surfaces 32 toprevent rolling of the device 10 when placed on a support surface and/orto distinguish the distal end 14 of the device 10 from the proximal end16 of the device 10.

As shown in FIG. 3B, some embodiments of the device 10 may include alabel or grip 36 with non-slip features (e.g., nubs, texturing, grooves,etc.) attached to an outer surface 12 o of the housing 12. The non-slipfeatures facilitate easy gripping of the device and may also identifythe end of the device 10. The non-slip features may also be molded intothe outer surface 12 o of the housing 12.

In various embodiments of the device 10, as shown in FIG. 3A, thehousing 12 may include two, opposing windows 70 (only one is visible)that allow the primary container 20, the drug 22 and the plunger 42 tobe viewed by the patient or user from either side of the device 10during the operation thereof. In such embodiments, the plunger 42operates to visually indicate the start, progress, and/or completion ofthe drug injection/extrusion process. As shown in FIG. 3B, the windows70 in some embodiments may each include a magnifying lens 72, whichfacilitates easy viewing of the primary container 20, drug 22 andplunger 42 by the patient or user. In other embodiments of the device,the housing 12 may include a single window 70.

Instead of the windows 70 shown in FIGS. 3A and 3B, some embodiments ofthe device 10 as shown in FIG. 3C may comprise a housing 12 having atransparent housing section 80. The transparent housing section 80allows 360 degrees of viewing of the primary container 20, drug 22 andplunger 42. Accordingly, the patient or user can easily watch theinjection/extrusion process from substantially any angle. Thetransparent housing section 80 may also be formed to magnify the primarycontainer 20, drug 22 and plunger 42, to facilitate easy viewingthereof.

In some embodiments of the device 10, the plunger 42 may have a vividcolor (e.g., green, red, etc.) to facilitate easy viewing thereof viathe windows 70 or transparent housing section 80.

Some embodiments of the device 10 may contain a drug 22 that requiresrefrigeration. Refrigerated drugs often increase the pain of injection.As the drug approaches room temperature, the pain of injection candecrease. Accordingly, various embodiments of the device 10 may includea temperature indicator 34, as shown in FIG. 1A. The temperatureindicator 34 may be provided, for example, on or in the housing 12 orcap 30 of the device 10. In other embodiments, the temperature indicator34 may comprise, for example, a simple binary visual indicator whichindicates that the drug 22 is sufficiently close to room temperature sothat injection of the drug can be carried out, or a thermometer.

The needle guard 50 and the housing 12 may be configured in someembodiments of the device 10 to visually indicate when injection needlepenetration will take place, that correct needle penetration depth hasbeen achieved, when the device 10 will deliver the drug 22, and when thedevice 10 has completed delivering the drug 22.

More specifically, as shown in FIG. 4A, the device 10 in variousembodiments may comprise a line or band 64 provided on the outer surface12 o of the housing 12 at the distal end 14 thereof. Further, the needleguard 50 may comprise distal and proximal outer surface portions 60 and58, respectively, which are visually distinguished from one another, forexample, by color, shade, or some other means. In one embodiment, thedistal needle guard surface portion 60 may be a first, vivid color(e.g., green, red, etc.) and the proximal needle guard surface portion58 may be a second vivid color (e.g., blue, yellow, etc.), which can beeasily distinguished from the first, vivid color. The proximal surfaceportion 58 of the second color may represent a “safe” mode whichvisually signals or indicates to the patient or user that the injectionneedle 24 of the device is not contacting or penetrating the skin at theinjection site. The distal surface portion 60 of the first color mayrepresent an “action” mode which visually signals or indicates to thepatient or user that the injection needle 24 of the device haspenetrated the skin at the correct depth. An outer rim 62 may beprovided adjacent to the distal end 54 of the needle guard 50. The rim62 may be the same vivid color as the distal surface portion 60 of thehousing 12 or any other suitably vivid color. The band 64 provided onthe outer surface 12 o of the housing 12 may be the same color as thedistal surface portion 60 of the housing 12 or any other suitable vividcolor.

FIGS. 5A-5D depict the operation of the needle guard 50 of FIG. 4A as avisual indicator, wherein at least one indicia disposed on the needleguard 50 provides a visual indication of the position of the needle 24relative to the injection site based on a position of the needle guard50 relative to the housing 12 of the device 10.

Referring first to FIG. 5A, the patient or user places the needle guard50 of the device 10 against the skin at an injection site such that theneedle guard 50 is fully extended so that the distal and proximalsurface portions 60 and 58, respectively, of the needle guard 50 areexposed outside of the housing and visible. In the fully extendedposition, the needle guard 50 extends from the housing 12 and beyond theportion of the needle 24 extending out of the housing 12 such that thevisible proximal surface portion 58 of the needle guard 50 visuallysignals or indicates that the injection needle 24 of the device 10 isnot making contact with or penetrating the skin at the injection siteand therefore, the device 10 is in the safe mode. If the housing 12 ofthe device 10 includes the earlier described window(s) 70 (shown inFIGS. 5A-5D) or transparent housing section 80, the primary container 20and the drug 22 may be visible therein in the safe mode. In someembodiments, the plunger 42 may also be visible in the safe mode andlocated in the proximal portion of the primary container 20. In anycase, the image in the window(s) 70 or transparent housing section 80provides a visual indication that the drug injection/extrusion processhas not commenced.

Referring to FIG. 5B, the device 10 has been pressed toward and againstthe skin at the injection site, which causes the proximal surfaceportion 58 of the needle guard 50 to move into the distal end 14 of thehousing 12, thereby occupying an intermediate position between fullyextended (FIG. 5A) and fully retracted positions (FIG. 5C). In thisintermediate position, the proximal outer surface portion 58 isconcealed inside the housing 12 and the distal outer surface portion 60is exposed outside of the housing 12. As shown, the device 10 has beenpressed toward the skin so that the proximal surface portion 58 of theneedle guard 50 is no longer visible and only the distal surface portion60 of the needle guard 50 is visible. The disappearance of the proximalsurface portion 58 of the needle guard 50 visually signals or indicatesthat further pressing of the device 10 toward the skin will cause theinjection needle 24 of the device to penetrate the skin at the injectionsite thereby placing the device 10 in the action mode. This is becausein this intermediate position, the needle guard 50 extends from thehousing 12 approximately the same distance that the needle 24 extendsout of the housing 12. In addition, the image viewable through thehousing window(s) 70 (or transparent housing section 80) visuallyindicates that the drug injection/extrusion process has not yetcommenced. Some embodiments of the device 10 may also be configured withat least one audible indicator mechanism 32 (FIG. 1A), which provides anaudible indication when the injection needle 24 is about to penetratethe skin. The audible indicator mechanism 32 can be configured toproduce an audible click, one or more beeps, or any other suitablesound, which can be easily heard. The audible indicator mechanism 32 cancomprise any suitable mechanical, electrical or electro-mechanicalarrangement for generating the audible indication.

Referring to FIG. 5C, the device 10 has been pressed further toward theskin at the injection site, which causes the distal surface portion 60of the needle guard 50 to move into the distal end 14 of the housing 12.The device 10 is pressed toward the skin until the distal surfaceportion 60 of the needle guard 50 is no longer visible except for therim 62 which engages the band 64 provided on the outer surface 12 o ofthe housing 12. In this fully retracted position, a substantial portionof the needle 24 extending out of the housing 12 is exposed beyond theneedle guard 50 and penetrating the patient, and both the proximal anddistal outer surface portions 58, 60 are concealed inside the housing12. The disappearance of the distal surface portion 60 of the needleguard 50 (except for the rim 62) visually signals or indicates that thecorrect depth of needle penetration has been achieved and that the drivemechanism 40 has been activated to commence injection/extrusion of thedrug 22. Upon commencement of drug the injection/extrusion process, theplunger 42 starts to move through the primary container 20 as can beseen through the housing window(s) 70 (or transparent housing section80), thereby providing another visual indication that theinjection/extrusion process has started. In addition to theaforementioned visual indicators, embodiments of the device 10configured with the audible indicator mechanism 32 (FIG. 1A) can alsoprovide an audible indication (e.g., one or more clicks, beeps, etc.)that the drive mechanism 40 has been activated to commence injection ofthe drug 22.

As the drug injection/extrusion process continues, the plunger's 42movement through the primary container 20 can be viewed by the patientor user through the window(s) 70 (or the transparent housing section 80)of the device housing 12. FIG. 5D shows the device 10 after thecompletion of the injection/extrusion process and the partial withdrawalof the device 10 from the skin at the injection site. As shown, theplunger 42 substantially fills the window(s) 70 (or transparent housingsection 80), thereby visually indicating that the druginjection/extrusion process is completed. Embodiments of the device 10having the audible indicator mechanism 32 (FIG. 1A) can be configured toalso provide an audible indication (e.g., one or more clicks, beeps,etc.) that the drug injection/extrusion process is completed. Withdrawalof the device 10 fully extends the needle guard 50 so that the proximalneedle guard surface portion 60 is visible, thereby visually indicatingto the patient or user that the device 10 is back in the safe mode whereinjection needle 24 of the device 10 is no longer penetrating orcontacting the skin at the injection site.

Once in the safe mode, the device 10 can be safely removed from theinjection site as the needle guard 50 is fully extended and surroundingthe injection needle 24. In some embodiments, the device 10 may beconfigured so that the needle guard 50 locks in place in the fullyextended position and cannot thereafter be moved from its lockedposition in the proximal direction relative to the housing 12 to exposethe injection needle 24. The used device 10 is, therefore, rendered safefor handling. In single-use embodiments, the device 10 can now be safelydiscarded. If configured as a reusable device, the primary container 20can now be discarded and replaced with a new primary container 20.

Referring to FIG. 1B, the audible indicator mechanism 32 mentionedearlier may comprise a speaker 32 sp, a circuit 32 c for driving thespeaker 32 s, a battery 32 b for powering the circuit 32 c, and a switch32 sw for activating the circuit 32 c. The switch 32 sw may be activatedby the motion of the needle guard 50. The speaker 32 sp may be similarto a cell phone speaker, which typically uses an electromagnet or smallcrystal to generate the vibrations. In some embodiments, the circuit 32c may include a read only memory for storing tone data, music, and/orother sounds. The circuit 32 c may also include logic for converting thetone data, music, and/or other sounds, to a signal that vibrates thespeaker 32 sp and timing logic for stepping through the memory. Theswitch 32 sw may comprise one of a reed switch, a capacitance switch, animpedance switch, and any other suitable switch that is capable oftransducing the motion of the needle guard 50.

FIG. 4B shows another embodiment of the needle guard 50′, which includestext-based indicia instead of color for visually indicating when thedevice 10 is in the safe mode and when the device 10 is in the actionmode, described earlier. The text-based indicia may comprise one or moreoccurrences of a word such as “SAFE” or any other suitable word orphrase disposed on the proximal outer surface portion 58′ of the needleguard 50′ and one or more occurrences a word such as “ACTION” and/or anyother suitable word or phrase disposed on the distal outer surfaceportion 60′ of the needle guard 50′.

In various other embodiments, the needle guard may include both color-and text-based indicia for visually indicating when the device is in thesafe mode and when the device is in the action mode as describedearlier. Alternatively, the needle guard may include image-based indiciafor visually indicating when the device is in the safe mode and when thedevice is in the action mode as described earlier. The image-basedindicia may comprise one or more occurrences of an image or symbolrepresenting the safe mode on the proximal outer surface portion of theneedle guard and one or more occurrences an image or symbol representingthe action mode on the distal outer surface portion of the needle guard.The image-based indicia may also be combined with the color- and/ortext-based indicia described earlier. In various other embodiments,distal and proximal portions of the needle guard may be configured sothat they can include symbols, graphics, patterns, or any other visualindication to indicate the safe and action modes. The selectedindication of the needle guard may be combined with any combination ofthe above-mentioned visual and audible indicators. In various otherembodiments, distal and proximal portions of the needle guard may beconfigured so that they can be selectively illuminated to indicate thesafe and action modes. The selected illumination of the needle guard maybe combined with any combination of the above-mentioned visual andaudible indicators.

FIG. 6A shows another embodiment of the device 10 comprising atelescoping needle guard denoted by reference numeral 90 occupying afully extended position. The telescoping needle guard 90 may compriseproximal (e.g., first) and distal (e.g., second) needle guard members 98and 100, respectively, each having an outer surface exposed outside ofthe housing 12 in FIG. 6A. An outer rim 92 may be disposed adjacent to adistal end 100 d of the distal needle guard member 100. The proximalneedle guard member 98 can be biased in a fully extended position withthe same biasing element 57 used to bias the previously described needleguards. A second biasing element 96, such as a coil spring, may beprovided to bias the distal needle guard member 100 in a fully extendedposition with respect to the proximal needle guard member 98. The secondbiasing element 96 should provide a lower biasing force than biasingelement 57, so that the distal needle guard member 100 moves from thefully extended position to a fully collapsed (e.g., retracted) positionbefore the proximal needle guard member 98 moves from the fully extendedposition to a fully collapsed (e.g., retracted) position within thehousing 12. The biasing element 96 may be disposed between an abutment100 a provided on an inner surface 100 i of the distal needle guardmember 100 adjacent to the distal end 100 d thereof and a distal edgesurface 98 es of the proximal needle guard member 98. The distal andproximal needle guard members 98, 100 can be configured with the color-,text-, image-based, and illuminated visual indicators described earlier.

As shown in FIGS. 6B and 6C, the telescoping needle guard 90 operates ina manner similar to the needle guards described earlier and inconjunction with the previously described audible indicators, exceptthat when the device 10 is pressed toward and against the skin at theinjection site, the distal needle guard member 100 slides over theproximal needle guard member 98 until it is no longer visible and onlythe distal needle guard member 100 of the telescoping needle guard 90 isvisible, as shown in FIG. 6C. In this intermediate position depicted inFIG. 6C, the outer surface of the proximal needle guard member 98 isconcealed inside the distal needle guard member 100, which itselfremains exposed outside of the housing 12. Similar to the needle guardsdescribed earlier, the disappearance of the proximal needle guard member98 visually indicates that further pressing of the device 10 toward theskin will cause the injection needle 24 of the device to penetrate theskin at the injection site thereby placing the device 10 in the actionmode.

As shown in FIG. 6D, when the device 10 is pressed further toward theskin at the injection site, the distal needle guard member 100 and theproximal needle guard member 98 disposed and concealed within the distalneedle guard member 100, both move together into the distal end 14 ofthe housing 12 until the distal needle guard member 100 is no longervisible except for the rim 92, which engages the band 64 provided on theouter surface 12 o of the housing 12. In this fully retracted position,the outer surfaces of the proximal and distal needle guard members 98are concealed inside the housing 12. As with the needle guards describedearlier, the disappearance of the distal needle guard member 100 (exceptof the rim 92) visually indicates that the correct needle penetrationdepth has been achieved and the drive mechanism 40 has been activated tocommence injection/extrusion of the drug 22.

FIG. 7A shows another embodiment of the device 10 comprising analternate version of the telescoping needle guard denoted by referencenumeral 90′ occupying a fully extended position. The telescoping needleguard 90′ is similar to the telescoping needle guard 90 of FIGS. 6A-6D,except the distal and proximal needle guard members 98′, 100′ areconfigured so that the distal needle guard member 100′ collapses intoand inside of the proximal needle guard 98′ in the intermediate andfully retracted positions, instead of over it as in the telescopingneedle guard of FIGS. 6A-6C. Further, an outer rim 92′ is provided onthe proximal needle guard member 98′ adjacent to the distal end 98 e′thereof. A second biasing element 96′, such as a coil spring, may beprovided to bias the distal needle guard member 100′ in a fully extendedposition with respect to the proximal needle guard member 98′. Thebiasing element 96′ may be disposed between a proximal edge surface 100e′ of the distal needle guard member 100′ and an abutment 98 a′ providedon an inner surface 98 i′ of the proximal needle guard member 98′adjacent to a proximal end 98 p′ thereof. The second biasing element 96′should provide a lower biasing force than biasing element 57 so that thedistal needle guard member 100′ moves from the fully extended positionto a fully collapsed (e.g., retracted) position before the proximalneedle guard member 98′ moves from the fully extended position to afully collapsed (e.g., retracted) position within the housing 12. Thedistal and proximal needle guard members 98′, 100′ can be configuredwith the color-, text-, image-based, and illuminated visual indicatorsdescribed earlier.

As shown in FIGS. 7B-7D, the telescoping needle guard 90′ operates in amanner similar to the previously described needle guards and inconjunction with the previously described audible indicators, exceptwhen the device 10 is pressed toward and against the skin at theinjection site, the distal needle guard member 100′ slides into theproximal needle guard member 98′ until it is no longer visible and onlythe proximal needle guard member 98′ of the telescoping needle guard 90′is visible. Further, in contrast to the previously described needleguards, the disappearance of the distal needle guard member 100′visually indicates that further pressing of the device 10 toward theskin will cause the injection needle 24 of the device to penetrate theskin at the injection site thereby placing the device 10 in the actionmode.

In FIG. 7B, the needle guard 90′ occupies the fully extended positionwhereby the outer surfaces of the proximal and distal needle guardmembers 98′, 100′ are exposed outside of the housing 12. Further, asshown in FIG. 7C, the needle guard 90′ moves into an intermediateposition when the device 10 is pressed further toward the skin at theinjection site and the distal needle guard member 100′ becomes disposedand concealed within the proximal needle guard member 98′. Further forceapplied to the device 10 causes both the proximal and distal needleguard members 98′, 100′ to move together into and become concealedwithin the distal end 14 of the housing 12. In this fully retractedposition depicted in FIG. 7D, the proximal needle guard member 98′ is nolonger visible except for the rim 92′, which engages the band 64provided on the outer surface 12 o of the housing 12. In furthercontrast to the previously described needle guards, the disappearance ofthe proximal needle guard member 98′ (except for the rim 92′) visuallyindicates that the correct needle penetration depth has been achievedand the drive mechanism 40 has been activated to commenceinjection/extrusion of the drug 22.

Referring now to FIG. 8, there is shown an embodiment of a druginjection device tray according to the present disclosure, denotedgenerally by reference numeral 110. The tray 110 may be used forallowing the patient or user to visually confirm that the drug 22contained in the primary container 20 of the device 10 is particle-free(clear) and/or colorless. The tray 110 may also be used with any otherdrug injection device which allows viewing of the drug containedtherein. Further, the tray may 110 also be used for packaging the druginjection device 10 or any other drug injection device.

As shown in FIG. 8, various embodiments of the tray 110 may comprise aflat, elongated, support wall 112 with inner side walls 114 extendingbetween the support wall 112 and an inner edge 116 i of a rim surface116 extending about an outer periphery 118 of the tray 110 above thesupport wall 112. Outer side walls 120 may extend from an outer edge 116o of the rim surface 116 to support the tray 110. The support wall 112may include a first recess 122 shaped and dimensioned for securelyreceiving the drug injection device 10 or any other injection device.The support wall 112 may further include a second recess 124 extendingtransversely to the first recess 122, which allows the patient or userto grip the device 10 with their fingers and remove it from the firstrecess 122 of the tray 110. The second recess 124 may be configured asshown to communicate with a portion 122 p of the first recess so thatthe fingers can reach under the device 10 and grasp it. The first andsecond recesses 122, 124 may be configured so that they do not extendbelow supporting edges (not visible) of the outer side walls 120 of thetray 110. The tray 110 may be made from any suitable material includingfolded sheet metal and injection molded plastic.

Still referring to FIG. 8, the first recess 124 may include a first drugtest surface 126. The first drug test surface 126 may be located atleast partially under an adjacent one of the opposing windows 70 (shownin FIG. 8) or a portion of the transparent housing section 80 (notshown) of the device housing 12 when the device 10 is seated in thefirst recess 122. The first drug test surface 126 optionally extendsonto the support wall 112 as shown in FIG. 8. The first drug testsurface 126 may, for example, comprise an adhesively bonded label or bea unitarily formed section of the first recess 122 (and support wall112). The first drug test surface 126 may be configured for determiningor checking the clarity of the drug 22 (shown in FIG. 8) or the color ofthe drug 22. The patient or user can make this determination by viewingthe drug 22 through the window(s) 70 or the transparent housing section80 of the device housing 12 and comparing the drug 22 with the drug testsurface 126, which forms a background for the drug 22. When determiningor checking the clarity of the drug 22 (shown in FIG. 8), the first drugtest surface 126 may be configured as a dark color (e.g., black), whichallows easy visual identification of particles and/or cloudiness in thedrug 22 if, for example, the drug should be clear. The first drug testsurface 126 may also include text- and/or image-based indicia 126 i thatinstruct the patient or user to check the clarity of the drug 22. Whendetermining or checking the color of the drug 22, the drug test surface126 may be configured as a light color (e.g., white), which allows easyvisual identification of whether the drug 22 is colored if, for example,the drug 22 should be colorless. The first drug test surface 126 mayalso include text- and/or image-based indicia (not shown) that instructthe patient or user to check the color of the drug 22.

The first recess 124 may further include a second drug test surface 128.The second test surface 128 may be located next to the first drug testsurface 126 under another portion of the adjacent window 70 (shown inFIG. 8) or transparent housing section 80 (not shown) of the devicehousing 12 when the device 10 is seated in the first recess 122. Thesecond drug test surface 128 may optionally extend onto the support wall112 as shown in FIG. 8. The second drug test surface 128 may, forexample, comprise an adhesively bonded label or be a unitarily formedsection of the first recess 122 (and support wall 112). The second drugtest surface 128 may be configured for determining or checking theclarity of the drug 22 or the color of the drug 22 (shown in FIG. 8), asdescribed earlier where the patient or user views the drug 22 throughthe window(s) 70 or portion of the transparent housing section 80 of thedevice housing 12 and comparing the drug 22 with the second drug testsurface 128, which forms a background for the drug 22. When determiningor checking the clarity of the drug 22, the second drug test surface 128may be configured as a dark color (e.g., black), which allows easyvisual identification of particles and/or cloudiness in the drug 22 if,for example, the drug should be clear. The second drug test surface 128may also include text- and/or image-based indicia (not shown) thatinstruct the patient or user to check the clarity of the drug 22. Whendetermining or checking the color of the drug 22 (shown in FIG. 8), thesecond drug test surface 128 may be configured as a light color (e.g.,white), which allows easy visual identification of whether the drug 22is colored if, for example, the drug 22 should be colorless. The seconddrug test surface 128 may also include text- and/or image-based indicia128 i that instruct the patient or user to check the color of the drug22.

Referring now to FIGS. 9A-9C, there is shown an embodiment of theinjection device with a removable drug injection device label accordingto the present disclosure. The label is denoted generally by referencenumeral 140. The label 140 allows the patient or user to observe thedrug 22 (FIG. 9C) contained in the primary container 20 of the device 10and confirm that it is particle-free (clear) and/or colorless. The label140 may also serve as a tamper indicator for indicating whether the druginjection device 10 has been tampered with or previously used. It iscontemplated that the label 140 can be used with any drug injectiondevice that allows viewing of the drug contained therein.

As best shown in FIG. 9C, the removable label 140 includes a top edge146, a bottom edge 148, and first and second side edges 150 and 152,respectively, an outer surface 142 (FIG. 9B), an inner surface 144. Apull tab 154 may be provided on the top edge 146 (shown in FIGS. 9A-9C)or the bottom edge 148 of the label 140 for facilitating the opening orpeeling of the label 140.

As shown in FIG. 9B, the label 140 wraps around the housing 12 of thedevice 10 so that the inner surface 144 of the label 140 covers both thewindows 70 (shown in FIGS. 9A and 9C) or the transparent housing section80 (not shown) of the device housing 12. The label 140 may be configuredto also wrap around a proximal portion of the cap 30 of the device 10,thereby serving as a tamper indicator for indicating whether the druginjection device 10 has been tampered with or previously used. The innersurface 144 of the label 140 may include an adhesive (not shown) forremovably bonding the label to the housing 12 (and the cap 30).

As shown in FIG. 9B, the outer surface 142 of the label 140 may includetext- and/or image-based indicia 142 i that instruct the patient or userto pull the tab 154 and check the drug contained in the primarycontainer of the device 10.

As best shown in FIG. 9C, an intermediate section of the inner surface144 of the label 140 may include a first drug test surface 156. When thelabel 140 is applied to the device 10, the first drug test surface 156is located at least partially under an adjacent one of the opposingwindows 70 (shown in FIG. 9C) or the transparent housing section 80 (notshown) of the device housing 12. The first drug test surface 156 may beconfigured for determining or checking the clarity of the drug 22 (shownin FIG. 9C) or the color of the drug 22. The patient or user can makethis determination by grasping the pull tab 154 and peeling back anupper portion 140 u of the label 140 from the housing 12 to reveal oneof the windows 70 (shown in FIG. 9C) or the transparent housing section80 (not shown) of the device housing 12. The drug, which is visiblethrough the revealed window 70 or the portion of the transparent housingsection 80 of the device housing 12 facing the patient or user, can thenbe compared with the first drug test surface 156, which forms abackground for the drug 22. When determining or checking the clarity ofthe drug 22 (shown in FIG. 9C), the first drug test surface 156 may beconfigured as a dark color (e.g., black), which allows easy visualidentification of particles and/or cloudiness in the drug 22 if, forexample, the drug 22 should be clear. When determining or checking thecolor of the drug 22, the drug test surface 156 may be configured as alight color (e.g., white), which allows easy visual identification ofwhether the drug 22 is colored if, for example, the drug 22 should becolorless. The inner surface 144 u of the upper portion 140 u of thelabel 140 may also include text- and/or image-based indicia 144 ui thatinstruct the patient or user to check the clarity of the drug 22 (shownin FIG. 9C) or the color of the drug 22.

As best shown in FIG. 9C, the intermediate section of the inner surface144 of the label 140 may also include a second drug test surface 158.The second drug test surface 158 may be located next to the first drugtest surface 156 under a portion of the adjacent one of the opposingwindows 70 (shown in FIG. 9C) or the transparent housing section 80 (notshown) of the device housing 12. The second drug test surface 158 may beconfigured for determining or checking the clarity of the drug 22 or thecolor of the drug 22 (shown in FIG. 9C) after the upper portion 140 u ofthe label 140 has been pulled back from the housing to reveal one of thewindows 70 (shown in FIG. 9C) or the portion transparent housing section80 (not shown) of the device housing 12, as described earlier. The drug22 can then be compared with the second drug test surface 158, whichforms a background for the drug 22. When determining or checking theclarity of the drug 22, the second drug test surface 158 may beconfigured as a dark color (e.g., black), which allows easy visualidentification of particles and/or cloudiness in the drug 22 if, forexample, the drug should be clear. When determining or checking thecolor of the drug 22 (shown in FIG. 9C), the second drug test surface158 may be configured as a light color (e.g., white), which allows easyvisual identification of whether the drug 22 is colored if, for example,the drug 22 should be colorless.

The label 140 may be dimensioned so that a lower portion 1401 of thelabel 140 is covered by the upper portion 140 u of the label 140 (shownin FIG. 9B) prior to peeling or unwrapping. In addition the innersurface 1441 of the lower portion 1401 of the label 140 may be devoid ofadhesive. Therefore, when the upper label portion 140 u is peeled backto check the drug 22, the lower label portion 1401 releases from thehousing 12 (and cap 30) as shown in FIGS. 9A and 9C. The inner surface1441 of the lower label portion 1401 may include text- and/orimage-based indicia 1441 i that instruct the patient or user regardingwhether the use of the injector after checking the drug 22. For examplethe indicia 1441 i may instruct the patient or user to remove the label140 from the device 10 if the drug 22 is clear and/or colorless, or notuse the device 10 if the drug 22 is not clear and/or not colorless.

The above description describes various systems and methods for use witha drug delivery device. It should be clear that the system, drugdelivery device or methods can further comprise use of a medicamentlisted below with the caveat that the following list should neither beconsidered to be all inclusive nor limiting. The medicament will becontained in a container of the device. In some instances, the containeris a primary container that is either filled or pre-filled for treatmentwith the medicament. The primary container can be a cartridge or apre-filled syringe.

For example, the drug delivery device or more specifically the containerof the device may be filled with colony stimulating factors, such asgranulocyte colony-stimulating factor (G-CSF). Such G-CSF agentsinclude, but are not limited to, Neupogen® (filgrastim) and Neulasta®(pegfilgrastim). In various other embodiments, the drug delivery devicemay be used with various pharmaceutical products, such as anerythropoiesis stimulating agent (ESA), which may be in a liquid or alyophilized form. An ESA is any molecule that stimulates erythropoiesis,such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo®(epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta),Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon®(epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa),epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta),Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa,epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well asthe molecules or variants or analogs thereof as disclosed in thefollowing patents or patent applications: U.S. Pat. Nos. 4,703,008;5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078;5,773,569; 5,955,422; 5,986,047; 6,583,272; 7,084,245; and 7,271,689;and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 96/40772; WO00/24893; WO 01/81405; and WO 2007/136752.

An ESA can be an erythropoiesis stimulating protein. As used herein,“erythropoiesis stimulating protein” means any protein that directly orindirectly causes activation of the erythropoietin receptor, forexample, by binding to and causing dimerization of the receptor.Erythropoiesis stimulating proteins include erythropoietin and variants,analogs, or derivatives thereof that bind to and activate erythropoietinreceptor; antibodies that bind to erythropoietin receptor and activatethe receptor; or peptides that bind to and activate erythropoietinreceptor. Erythropoiesis stimulating proteins include, but are notlimited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega,epoetin iota, epoetin zeta, and analogs thereof, pegylatederythropoietin, carbamylated erythropoietin, mimetic peptides (includingEMP1/hematide), and mimetic antibodies. Exemplary erythropoiesisstimulating proteins include erythropoietin, darbepoetin, erythropoietinagonist variants, and peptides or antibodies that bind and activateerythropoietin receptor (and include compounds reported in U.S.Publication Nos. 2003/0215444 and 2006/0040858) as well aserythropoietin molecules or variants or analogs thereof as disclosed inthe following patents or patent applications: U.S. Pat. Nos. 4,703,008;5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078;5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086;6,310,078; 6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369;7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002/0155998;2003/0077753; 2003/0082749; 2003/0143202; 2004/0009902; 2004/0071694;2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824;2004/0229318; 2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834;2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564;2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822;2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211;2005/0202538; 2005/0227289; 2005/0244409; 2006/0088906; and2006/0111279; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO99/66054; WO 00/24893; WO 01/81405; WO 00/61637; WO 01/36489; WO02/014356; WO 02/19963; WO 02/20034; WO 02/49673; WO 02/085940; WO03/029291; WO 2003/055526; WO 2003/084477; WO 2003/094858; WO2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; WO2005/001025; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO2006/29094.

Examples of other pharmaceutical products for use with the device mayinclude, but are not limited to, antibodies such as Vectibix®(panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); otherbiological agents such as Enbrel® (etanercept, TNF-receptor/Fc fusionprotein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim,pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF,hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such asSensipar® (cinacalcet). The device may also be used with a therapeuticantibody, a polypeptide, a protein or other chemical, such as an iron,for example, ferumoxytol, iron dextrans, ferric glyconate, and ironsucrose. The pharmaceutical product may be in liquid form, orreconstituted from lyophilized form.

Among particular illustrative proteins are the specific proteins setforth below, including fusions, fragments, analogs, variants orderivatives thereof:

OPGL specific antibodies, peptibodies, and related proteins, and thelike (also referred to as RANKL specific antibodies, peptibodies and thelike), including fully humanized and human OPGL specific antibodies,particularly fully humanized monoclonal antibodies, including but notlimited to the antibodies described in PCT Publication No. WO 03/002713,as to OPGL specific antibodies and antibody related proteins,particularly those having the sequences set forth therein, particularly,but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1;and 22B3, including the OPGL specific antibodies having either the lightchain of SEQ ID NO:2 as set forth therein in FIG. 2 and/or the heavychain of SEQ ID NO:4, as set forth therein in FIG. 4,

Myostatin binding proteins, peptibodies, and related proteins, and thelike, including myostatin specific peptibodies, particularly thosedescribed in U.S. Publication No. 2004/0181033 and PCT Publication No.WO 2004/058988, particularly in parts pertinent to myostatin specificpeptibodies, including but not limited to peptibodies of the mTN8-19family, including those of SEQ ID NOS:305-351, including TN8-19-1through TN8-19-40, TN8-19 con1 and TN8-19 con2; peptibodies of the mL2family of SEQ ID NOS:357-383; the mL15 family of SEQ ID NOS:384-409; themL17 family of SEQ ID NOS:410-438; the mL20 family of SEQ IDNOS:439-446; the mL21 family of SEQ ID NOS:447-452; the mL24 family ofSEQ ID NOS:453-454; and those of SEQ ID NOS:615-631;

IL-4 receptor specific antibodies, peptibodies, and related proteins,and the like, particularly those that inhibit activities mediated bybinding of IL-4 and/or IL-13 to the receptor, including those describedin PCT Publication No. WO 2005/047331 or PCT Application No.PCT/US2004/37242 and in U.S. Publication No. 2005/112694, pertinent toIL-4 receptor specific antibodies, particularly such antibodies as aredescribed therein, particularly, and without limitation, thosedesignated therein: L1H1; L1H2; L1H3; L1H4; L1H5; L1H6; L1H7; L1H8;L1H9; L1H10; L1H11; L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8;L2H9; L2H10; L2H11; L2H12; L2H13; L2H14; L3H1; L4H1; L5H1; L6H1;

Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies,and related proteins, and the like, including but not limited to thosedescribed in U.S. Publication No. 2004/097712, in parts pertinent toIL1-R1 specific binding proteins, monoclonal antibodies in particular,especially, without limitation, those designated therein: 15CA, 26F5,27F2, 24E12, and 10H7;

Ang2 specific antibodies, peptibodies, and related proteins, and thelike, including but not limited to those described in PCT PublicationNo. WO 03/057134 and U.S. Publication No. 2003/0229023, in partspertinent to Ang2 specific antibodies and peptibodies and the like,especially those of sequences described therein and including but notlimited to: L1(N); L1(N) WT; L1(N) 1K WT; 2xL1(N); 2xL1(N) WT; Con4 (N),Con4 (N) 1K WT, 2xCon4 (N) 1K; L1C; L1C 1K; 2xL1C; Con4C; Con4C 1K;2xCon4C 1K; Con4-L1 (N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N);TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies andformulations such as those described in PCT Publication No. WO2003/030833, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536;Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558;Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK; AbG1D4; AbGC1E8; AbH1C12;AblA1; AblF; AblK, AblP; and AblP, in their various permutations asdescribed therein;

NGF specific antibodies, peptibodies, and related proteins, and the likeincluding, in particular, but not limited to those described in U.S.Publication No. 2005/0074821 and U.S. Pat. No. 6,919,426, as toNGF-specific antibodies and related proteins in this regard, includingin particular, but not limited to, the NGF-specific antibodies thereindesignated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11;

CD22 specific antibodies, peptibodies, and related proteins, and thelike, such as those described in U.S. Pat. No. 5,789,554, as to CD22specific antibodies and related proteins, particularly human CD22specific antibodies, such as but not limited to humanized and fullyhuman antibodies, including but not limited to humanized and fully humanmonoclonal antibodies, particularly including but not limited to humanCD22 specific IgG antibodies, such as, for instance, a dimer of ahuman-mouse monoclonal hLL2 gamma-chain disulfide linked to ahuman-mouse monoclonal hLL2 kappa-chain, including, but limited to, forexample, the human CD22 specific fully humanized antibody inEpratuzumab, CAS registry number 501423-23-0;

IGF-1 receptor specific antibodies, peptibodies, and related proteins,and the like, such as those described in PCT Publication No. WO06/069202, as to IGF-1 receptor specific antibodies and relatedproteins, including but not limited to the IGF-1 specific antibodiestherein designated L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9,L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18,L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27,L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36,L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45,L46H46, L47H47, L48H48, L49H49, L50H50, L51H51, L52H52, andIGF-1R-binding fragments and derivatives thereof;

Also among non-limiting examples of anti-IGF-1R antibodies for use inthe methods and compositions of the present invention are each and allof those described in:

(i) U.S. Publication No. 2006/0040358 (published Feb. 23, 2006),2005/0008642 (published Jan. 13, 2005), 2004/0228859 (published Nov. 18,2004), including but not limited to, for instance, antibody 1A (DSMZDeposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC 2589),antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 as describedtherein;

(ii) PCT Publication No. WO 06/138729 (published Dec. 28, 2006) and WO05/016970 (published Feb. 24, 2005), and Lu et al. (2004), J. Biol.Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12,and IMC-A12 as described therein;

(iii) PCT Publication No. WO 07/012614 (published Feb. 1, 2007), WO07/000328 (published Jan. 4, 2007), WO 06/013472 (published Feb. 9,2006), WO 05/058967 (published Jun. 30, 2005), and WO 03/059951(published Jul. 24, 2003);

(iv) U.S. Publication No. 2005/0084906 (published Apr. 21, 2005),including but not limited to antibody 7C10, chimaeric antibody C7C10,antibody h7C10, antibody 7H2M, chimaeric antibody *7C10, antibody GM607, humanized antibody 7C10 version 1, humanized antibody 7C10 version2, humanized antibody 7C10 version 3, and antibody 7H2HM, as describedtherein;

(v) U.S. Publication Nos. 2005/0249728 (published Nov. 10, 2005),2005/0186203 (published Aug. 25, 2005), 2004/0265307 (published Dec. 30,2004), and 2003/0235582 (published Dec. 25, 2003) and Maloney et al.(2003), Cancer Res. 63:5073-5083, including but not limited to antibodyEM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1,huEM164 v1.2, and huEM164 v1.3 as described therein;

(vi) U.S. Pat. No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos.2005/0244408 (published Nov. 30, 2005) and 2004/0086503 (published May6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073,e.g., antibody CP-751,871, including but not limited to each of theantibodies produced by the hybridomas having the ATCC accession numbersPTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, andantibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, asdescribed therein;

(vii) U.S. Publication Nos. 2005/0136063 (published Jun. 23, 2005) and2004/0018191 (published Jan. 29, 2004), including but not limited toantibody 19D12 and an antibody comprising a heavy chain encoded by apolynucleotide in plasmid 15H12/19D12 HCA (γ4), deposited at the ATCCunder number PTA-5214, and a light chain encoded by a polynucleotide inplasmid 15H12/19D12 LCF (κ), deposited at the ATCC under numberPTA-5220, as described therein; and

(viii) U.S. Publication No. 2004/0202655 (published Oct. 14, 2004),including but not limited to antibodies PINT-6A1, PINT-7A2, PINT-7A4,PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3,PINT-11A4, PINT-11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2,PINT-12A3, PINT-12A4, and PINT-12A5, as described therein, particularlyas to the aforementioned antibodies, peptibodies, and related proteinsand the like that target IGF-1 receptors;

B-7 related protein 1 specific antibodies, peptibodies, related proteinsand the like (“B7RP-1,” also is referred to in the literature as B7H2,ICOSL, B7h, and CD275), particularly B7RP-specific fully humanmonoclonal IgG2 antibodies, particularly fully human IgG2 monoclonalantibody that binds an epitope in the first immunoglobulin-like domainof B7RP-1, especially those that inhibit the interaction of B7RP-1 withits natural receptor, ICOS, on activated T cells in particular,especially, in all of the foregoing regards, those disclosed in U.S.Publication No. 2008/0166352 and PCT Publication No. WO 07/011941, as tosuch antibodies and related proteins, including but not limited toantibodies designated therein as follow: 16H (having light chainvariable and heavy chain variable sequences SEQ ID NO:1 and SEQ ID NO:7respectively therein); 5D (having light chain variable and heavy chainvariable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H(having light chain variable and heavy chain variable sequences SEQ IDNO:3 and SEQ ID NO:10 respectively therein); 43H (having light chainvariable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO:14respectively therein); 41H (having light chain variable and heavy chainvariable sequences SEQ ID NO:5 and SEQ ID NO:13 respectively therein);and 15H (having light chain variable and heavy chain variable sequencesSEQ ID NO:4 and SEQ ID NO:12 respectively therein);

IL-15 specific antibodies, peptibodies, and related proteins, and thelike, such as, in particular, humanized monoclonal antibodies,particularly antibodies such as those disclosed in U.S. Publication Nos.2003/0138421; 2003/023586; and 2004/0071702; and U.S. Pat. No.7,153,507, as to IL-15 specific antibodies and related proteins,including peptibodies, including particularly, for instance, but notlimited to, HuMax IL-15 antibodies and related proteins, such as, forinstance, 14687;

IFN gamma specific antibodies, peptibodies, and related proteins and thelike, especially human IFN gamma specific antibodies, particularly fullyhuman anti-IFN gamma antibodies, such as, for instance, those describedin U.S. Publication No. 2005/0004353, as to IFN gamma specificantibodies, particularly, for example, the antibodies therein designated1118; 1118*; 1119; 1121; and 1121*. The entire sequences of the heavyand light chains of each of these antibodies, as well as the sequencesof their heavy and light chain variable regions and complementaritydetermining regions, as disclosed in the foregoing publication and inThakur et al. (1999), Mol. Immunol. 36:1107-1115. In addition,description of the properties of these antibodies provided in theforegoing publication. Specific antibodies include those having theheavy chain of SEQ ID NO:17 and the light chain of SEQ ID NO:18; thosehaving the heavy chain variable region of SEQ ID NO:6 and the lightchain variable region of SEQ ID NO:8; those having the heavy chain ofSEQ ID NO:19 and the light chain of SEQ ID NO:20; those having the heavychain variable region of SEQ ID NO:10 and the light chain variableregion of SEQ ID NO:12; those having the heavy chain of SEQ ID NO:32 andthe light chain of SEQ ID NO:20; those having the heavy chain variableregion of SEQ ID NO:30 and the light chain variable region of SEQ IDNO:12; those having the heavy chain sequence of SEQ ID NO:21 and thelight chain sequence of SEQ ID NO:22; those having the heavy chainvariable region of SEQ ID NO:14 and the light chain variable region ofSEQ ID NO:16; those having the heavy chain of SEQ ID NO:21 and the lightchain of SEQ ID NO:33; and those having the heavy chain variable regionof SEQ ID NO:14 and the light chain variable region of SEQ ID NO:31, asdisclosed in the foregoing publication. A specific antibody contemplatedis antibody 1119 as disclosed in the foregoing U.S. publication andhaving a complete heavy chain of SEQ ID NO:17 as disclosed therein andhaving a complete light chain of SEQ ID NO:18 as disclosed therein;

TALL-1 specific antibodies, peptibodies, and the related proteins, andthe like, and other TALL specific binding proteins, such as thosedescribed in U.S. Publication Nos. 2003/0195156 and 2006/0135431, as toTALL-1 binding proteins, particularly the molecules of Tables 4 and 5B;

Parathyroid hormone (“PTH”) specific antibodies, peptibodies, andrelated proteins, and the like, such as those described in U.S. Pat. No.6,756,480, particularly in parts pertinent to proteins that bind PTH;

Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, andrelated proteins, and the like, such as those described in U.S. Pat. No.6,835,809, particularly in parts pertinent to proteins that bind TPO-R;

Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, andrelated proteins, and the like, including those that target theHGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonalantibodies that neutralize hepatocyte growth factor/scatter (HGF/SF)described in U.S. Publication No. 2005/0118643 and PCT Publication No.WO 2005/017107, huL2G7 described in U.S. Pat. No. 7,220,410 and OA-5d5described in U.S. Pat. Nos. 5,686,292 and 6,468,529 and in PCTPublication No. WO 96/38557, particularly in parts pertinent to proteinsthat bind HGF;

TRAIL-R2 specific antibodies, peptibodies, related proteins and thelike, such as those described in U.S. Pat. No. 7,521,048, particularlyin parts pertinent to proteins that bind TRAIL-R2;

Activin A specific antibodies, peptibodies, related proteins, and thelike, including but not limited to those described in U.S. PublicationNo. 2009/0234106, particularly in parts pertinent to proteins that bindActivin A;

TGF-beta specific antibodies, peptibodies, related proteins, and thelike, including but not limited to those described in U.S. Pat. No.6,803,453 and U.S. Publication No. 2007/0110747, particularly in partspertinent to proteins that bind TGF-beta;

Amyloid-beta protein specific antibodies, peptibodies, related proteins,and the like, including but not limited to those described in PCTPublication No. WO 2006/081171, particularly in parts pertinent toproteins that bind amyloid-beta proteins. One antibody contemplated isan antibody having a heavy chain variable region comprising SEQ ID NO:8and a light chain variable region having SEQ ID NO:6 as disclosed in theforegoing publication;

c-Kit specific antibodies, peptibodies, related proteins, and the like,including but not limited to those described in U.S. Publication No.2007/0253951, particularly in parts pertinent to proteins that bindc-Kit and/or other stem cell factor receptors;

OX40L specific antibodies, peptibodies, related proteins, and the like,including but not limited to those described in U.S. Publication No.2006/0002929, particularly in parts pertinent to proteins that bindOX40L and/or other ligands of the OX40 receptor; and

Other exemplary proteins, including Activase® (alteplase, tPA); Aranesp®(darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1,Avonex® (interferon beta-la); Bexxar® (tositumomab, anti-CD22 monoclonalantibody); Betaseron® (interferon-beta); Campath® (alemtuzumab,anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade®(bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokinereceptor mAb); Enbrel® (etanercept, TNF-receptor/Fc fusion protein, TNFblocker); Eprex® (epoetin alfa); Erbitux® (cetuximab,anti-EGFR/HER1/c-ErbB-1); Genotropin® (somatropin, Human GrowthHormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb);Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab);insulin in solution; Infergen® (interferon alfacon-1); Natrecor®(nesiritide; recombinant human B-type natriuretic peptide (hBNP);Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide®(epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab,anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin);Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™(eculizumab); pexelizumab (anti-05 complement); Numax® (MEDI-524);Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio®(lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4);Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumabmertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega®(oprelvekin, human interleukin-11); Neulasta® (pegylated filgastrim,pegylated G-CSF, pegylated hu-Met-G-CSF); Neupogen® (filgrastim, G-CSF,hu-MetG-CSF); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonalantibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFαmonoclonal antibody); Reopro® (abciximab, anti-GP 1Ib/IIia receptormonoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin®(bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect®(basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 14687-CHO(anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri®(natalizumab, anti-α4integrin mAb); Valortim® (MDX-1303, anti-B.anthracis protective antigen mAb); ABthrax™; Vectibix® (panitumumab);Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portionof human IgG1 and the extracellular domains of both IL-1 receptorcomponents (the Type I receptor and receptor accessory protein)); VEGFtrap (Ig domains of VEGFR1 fused to IgG1 Fc); Zenapax® (daclizumab);Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan);Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonalantibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3/huFcfusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFαmAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb);HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab);M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab,anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficileToxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC);anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333(anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-CriptomAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019);anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb;anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb(MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMaxHepC); anti-IFNα mAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1RmAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12/1L23 mAb (CNTO1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513;anti-Mannose Receptor/hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRαantibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL Receptor-2 humanmAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; anti-ZP3 mAb(HuMax-ZP3); NVS Antibody #1; and NVS Antibody #2.

Also included can be a sclerostin antibody, such as but not limited toromosozumab, blosozumab, or BPS 804 (Novartis). Further included can betherapeutics such as rilotumumab, bixalomer, trebananib, ganitumab,conatumumab, motesanib diphosphate, brodalumab, vidupiprant,panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally,included in the device can be a monoclonal antibody (IgG) that bindshuman Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), e.g. U.S.Pat. No. 8,030,547, U.S. Publication No. 2013/0064825, WO2008/057457,WO2008/057458, WO2008/057459, WO2008/063382, WO2008/133647,WO2009/100297, WO2009/100318, WO2011/037791, WO2011/053759,WO2011/053783, WO2008/125623, WO2011/072263, WO2009/055783,WO2012/0544438, WO2010/029513, WO2011/111007, WO2010/077854,WO2012/088313, WO2012/101251, WO2012/101252, WO2012/101253,WO2012/109530, and WO2001/031007.

Also included can be talimogene laherparepvec or another oncolytic HSVfor the treatment of melanoma or other cancers. Examples of oncolyticHSV include, but are not limited to talimogene laherparepvec (U.S. Pat.Nos. 7,223,593 and 7,537,924); OncoVEXGALV/CD (U.S. Pat. No. 7,981,669);OrienX010 (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143);G207, 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002),Cancer Gene Ther., 9(12):967-978).

Also included are TIMPs. TIMPs are endogenous tissue inhibitors ofmetalloproteinases (TIMPs) and are important in many natural processes.TIMP-3 is expressed by various cells or and is present in theextracellular matrix; it inhibits all the major cartilage-degradingmetalloproteases, and may play a role in role in many degradativediseases of connective tissue, including rheumatoid arthritis andosteoarthritis, as well as in cancer and cardiovascular conditions. Theamino acid sequence of TIMP-3, and the nucleic acid sequence of a DNAthat encodes TIMP-3, are disclosed in U.S. Pat. No. 6,562,596, issuedMay 13, 2003. Description of TIMP mutations can be found in U.S.Publication No. 2014/0274874 and PCT Publication No. WO 2014/152012.

Also included are antagonistic antibodies for human calcitoningene-related peptide (CGRP) receptor and bispecific antibody moleculethat target the CGRP receptor and other headache targets. Furtherinformation concerning these molecules can be found in PCT ApplicationNo. WO 2010/075238.

Additionally, a bispecific T cell engager antibody (BiTe), e.g.Blinotumomab can be used in the device. Alternatively, included can bean APJ large molecule agonist e.g., apelin or analogues thereof in thedevice. Information relating to such molecules can be found in PCTPublication No. WO 2014/099984.

In certain embodiments, the medicament comprises a therapeuticallyeffective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLPreceptor antibody. Examples of anti-TSLP antibodies that may be used insuch embodiments include, but are not limited to, those described inU.S. Pat. Nos. 7,982,016, and 8,232,372, and U.S. Publication No.2009/0186022. Examples of anti-TSLP receptor antibodies include, but arenot limited to, those described in U.S. Pat. No. 8,101,182. Inparticularly preferred embodiments, the medicament comprises atherapeutically effective amount of the anti-TSLP antibody designated asA5 within U.S. Pat. No. 7,982,016.

Although the drug injection device, tray, elements thereof, methods, andsystems have been described in terms of illustrative embodiments, theyare not limited thereto. Rather, the appended claims should be construedbroadly to include other variants and embodiments of same, which may bemade by those skilled in the art without departing from the scope andrange of equivalents of the device, tray, elements methods, and systems.

What is claimed is:
 1. A drug injection device comprising: a housing forholding a container, the container storing a drug therein, the housingincluding at least one window that allows viewing of the drug in thecontainer; and a drug test surface disposed immediately adjacent to atleast a portion of the at least one window in the housing, such that thedrug in the container can be compared against the drug test surface todetermine at least one of a clarity or a color of the drug by viewingthe drug against the drug test surface through the at least one windowof the housing.
 2. The drug injection device of claim 1, wherein the atleast one window comprises two or more discrete windows that allowviewing of the drug in the container.
 3. The drug injection device ofclaim 1, wherein the at least one window comprises a transparent 360degree section of the housing of the container.
 4. The drug injectiondevice of claim 1, wherein the drug test surface is provided by aremovable label disposed over the housing, the label having first andsecond sections, the second section of the label that defines the drugtest surface.
 5. The drug injection device of claim 4, wherein the drugtest surface of the second section includes an area of a first color fortesting one of the clarity or the color of the drug.
 6. The druginjection device of claim 5, wherein the drug test surface of the secondsection includes an area of a second color for testing the other one ofthe clarity or the color of the drug.
 7. The drug injection device ofclaim 4, wherein the label covers at least a portion of the at least onewindow.
 8. The drug injection device of claim 7, wherein the secondsection of the label includes an inner surface that defines the drugtest surface; and removal of the first section of the label from thehousing exposes the drug test surface of the second section of the labelto be visible through the at least one window.
 9. The drug injectiondevice of claim 4, wherein the first section of the label has a firstinstruction to remove the first section to check the drug and a secondinstruction to determine the at least one of the clarity or the color ofthe drug.
 10. The drug injection device of claim 9, wherein the labelfurther includes a third section having a first instruction to removethe third section of the label if the at least one of the clarity or thecolor of the drug is determined to be proper and a second instruction tonot use the device if the at least one of the clarity or the color ofthe drug is determined to be improper.
 11. The drug injection device ofclaim 4, wherein the label includes a pull tab.
 12. The drug injectiondevice of claim 4, wherein the container includes a needle forpenetrating skin and dispensing the drug stored in the container, atleast a portion of the needle extending out of the housing and furthercomprising a cap for enclosing the at least portion of the needle. 13.The drug injection device of claim 12, wherein the label at leastpartially covers the cap acting as a tamper evident feature.
 14. Thedrug injection device of claim 1, wherein the drug test surface isprovided by a tray having a support wall defining a first recess adaptedto hold the housing; and the drug test surface is disposed on thesupport wall, at least a portion of the drug test surface being disposedin the first recess immediately adjacent to at least a portion of the atleast one window of the housing when the housing is disposed in thetray.
 15. The drug injection device of claim 14, wherein the drug testsurface is disposed under a section of the housing including the atleast one window if the device is disposed in the first recess.
 16. Thedrug injection device of claim 14, wherein the drug test surfaceincludes an instruction to determine the at least one of the clarity orthe color of the drug.
 17. The drug injection device of claim 14,further comprising a second recess extending transverse to the firstrecess to allow for removal of the housing from the tray.
 18. The druginjection device of claim 14, wherein the drug test surface includes anarea of a first color for testing one of the clarity or the color of thedrug.
 19. The drug injection device of claim 18, wherein the drug testsurface includes an area of a second color for testing the other one ofthe clarity or the color of the drug.
 20. The drug injection device ofclaim 14, wherein the drug test surface is defined by a label disposedon the support wall.